Irinotecan Liposome(II) Combined With Ivonescimab as Second-line Treatment for Small Cell Lung Cancer : A Prospective, Single-arm, Multicenter Clinical Study

NCT06820762 | Not Yet Recruiting Phase 2

• 1 other identifier: HR070803-SCLC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC.

Conditions

SCLC

Keywords

SCLC，irinotecan liposome(II)，Ivonescimab

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).

  Up to approximately 2 years

Secondary Outcomes (4)

• Objective response rate（ORR）

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

• Treatment related adverse events (TRAEs)

  Up to 30 days after last treatment

Study Arms (1)

Experimental: Irinotecan liposome (II) combined with ivonescimab

EXPERIMENTAL

Subjects will be administered with irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity

Drug: irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity

Interventions

irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity DRUG

Drug: ivonescimab 20mg/kg, IV, D1, Q3W Other Names: AK112 Drug: irinotecan liposome(II) 70mg/m\^2, IV, D1, Q3W

Experimental: Irinotecan liposome (II) combined with ivonescimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Histologically or cytologically confirmed SCLC;
• Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
• The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
• Life expectancy of ≥3 months;
• At least one measurable lesion is present according to the efficacy evaluation criteria for RECIST 1.1（Lesions that have received radiotherapy within 6 months prior to the first dose cannot be used as target lesions）
• No untreated central nervous system (CNS) metastases or CNS were stable for ≥1 month after treatment
• Have adequate organ function;
• All female must have had a negative serum pregnancy test within 72 hours of the first dosing and not be lactating, and study participants and their partners must use effective contraception during the trial and for 6 months after the last dosing of the trial drug.
• Able and willing to provide a written informed consent;

You may not qualify if:

• Known allergy to irinotecan hydrochloride liposome injection (II) and eboxizumab or drug excipients
• History of severe active autoimmune disease
• Participated in other drug studies within 4 weeks before enrollment
• Imaging during the screening period showed that the tumor surrounded important blood vessels or had significant necrosis and voids, and the investigators determined that entering the study would cause bleeding risk
• History of major illness within 1 year before the first medication
• History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistula, intraperitoneal abscess, or acute gastrointestinal bleeding within 6 months prior to initial administration
• History of surgery or severe trauma within 4 weeks prior to initial dosing
• Evidence and history of severe bleeding tendency;
• Participants who had received or planned to receive a live vaccine within 4 weeks prior to the first study treatment
• Patients with other cancer in 3 years,exceptions are adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• History of alcohol abuse, psychotropic substance abuse or drug abuse. Other conditions considered unsuitable for this study by the investigator.

Sponsors & Collaborators

• The Second Affiliated Hospital of Dalian Medical University: lead
• Shengjing Hospital: collaborator

Study Sites (2)

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116027, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110022, China

Location

Related Publications (3)

• Spigel DR, Dowlati A, Chen Y, Navarro A, Yang JC, Stojanovic G, Jove M, Rich P, Andric ZG, Wu YL, Rudin CM, Chen H, Zhang L, Yeung S, Benzaghou F, Paz-Ares L, Bunn PA; RESILIENT Trial Investigators. RESILIENT Part 2: A Randomized, Open-Label Phase III Study of Liposomal Irinotecan Versus Topotecan in Adults With Relapsed Small Cell Lung Cancer. J Clin Oncol. 2024 Jul 1;42(19):2317-2326. doi: 10.1200/JCO.23.02110. Epub 2024 Apr 22.

  PMID: 38648575 BACKGROUND

• Chen Z, Wu L, Wang Q, Yu Y, Liu X, Ma R, Li T, Li Y, Song X, Li L, Zhao W, Wang Q, Xu X, Lu S. Brief Report: Ivonescimab Combined With Etoposide Plus Carboplatin as First-Line Treatment for Extensive-Stage SCLC: Results of a Phase 1b Clinical Trial. J Thorac Oncol. 2025 Feb;20(2):233-239. doi: 10.1016/j.jtho.2024.10.013. Epub 2024 Oct 28.

  PMID: 39490738 BACKGROUND

• Li L, Liu T, Liu Q, Mu S, Tao H, Yang X, Li Y, Xiong Q, Wang L, Hu Y. Rechallenge of immunotherapy beyond progression in patients with extensive-stage small-cell lung cancer. Front Pharmacol. 2022 Sep 6;13:967559. doi: 10.3389/fphar.2022.967559. eCollection 2022.

  PMID: 36147357 BACKGROUND

Study Officials

• Wei Zheng, MD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Zhaoxia Dai, MD

  The Second Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jincheng Song, MD

CONTACT

0411-84671291-6152; wwepqwq@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-01

Locations

CN (2)